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. 2018 Aug 6;18(1):317.
doi: 10.1186/s12884-018-1956-1.

Women's experiences of being invited to participate in a case-control study of stillbirth - findings from the Midlands and North of England Stillbirth Study

Jayne Budd  1   2 , Tomasina Stacey  3 , Bill Martin  4 , Devender Roberts  5 , Alexander E P Heazell  6   7
Affiliations

Women's experiences of being invited to participate in a case-control study of stillbirth - findings from the Midlands and North of England Stillbirth Study

Jayne Budd et al. BMC Pregnancy Childbirth. .

Abstract

Background: The Midlands and North of England Stillbirth Study (MiNESS) was a case-control study of women who had a stillbirth or who had an ongoing pregnancy. During the set up phase questions were raised about whether interviewing women within six weeks of a stillbirth and recruiting women who were still pregnant into a "stillbirth" study was acceptable. This led to the research questions "whether it is appropriate to ask women who have recently experienced a stillbirth to participate in research?" and "whether it is appropriate to ask pregnant women to participate in a research project looking at factors associated with stillbirth." This nested study aimed to describe the opinions of women approached to participate in MiNESS to explore their views and experiences of a research project focussed on stillbirth.

Methods: Semi- structured interviews were conducted at a single study site involved in MiNESS. Purposive sampling was used to obtain a sample of women who were approached following a stillbirth (case n = 6) and those who were approached during pregnancy who gave birth to a live born baby (control n = 6). These two groups of women were divided equally according to whether they participated in the main MiNESS questionnaire study and those who declined to do so (n = 3 in each group). Interview data were transcribed and analysed using thematic analysis to identify the most important factors in determining whether women participated in MiNESS.

Results: The following themes emerged from the analysis: participants' understanding of research; approach by researcher; wanting to help; stillbirth taboo. These themes are explored individually in the manuscript. Participants reported positive views about research and previous participation in research studies. Respondents valued an initial approach from a member of staff already known to them. The taboo around stillbirth was a barrier to participation for some women with ongoing pregnancies.

Conclusions: Experiences and views regarding research differed between participants and non-participants in the MiNESS study. Participants reported a greater understanding of the importance and implications of clinical research. When designing future studies, the timing of approach, clarity of information and the person approaching potential participants should be considered to optimise recruitment.

Trial registration: NCT02025530 date registered: 01/01/2014.

Keywords: Research participation; Research recruitment; Stillbirth.

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Conflict of interest statement

Greater Manchester Central Ethics Committee Reference 13/NW/0874.

A favourable opinion was given by the committee for the study on 20/01/2014, with additional approval being given to the nested study on 24/07/2015. The ethics committee approved verbal consent from participants.

Not applicable.

Professor Alexander Heazell declares the role of Associate Editor for the journal. All other authors declare that they have no competing interests.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schematic representation of how participants were grouped in this nested case-control study
Fig. 2
Fig. 2
Schematic representation of themes which may exert a positive or negative influence on a woman’s willingness to participate in a research project relating to stillbirth
See this image and copyright information in PMC

References

    1. Manktelow BN, Smith LK, Prunet C, Smith PW, Boby T, Hyman-Taylor P, Kurinczuk JJ, Field DJ, Draper ES, on behalf of the MBRRACE-UK collaboration. MBRRACE-UK perinatal mortality surveillance report, UK perinatal deaths for births from January to December 2015. Leicester: The Infant Mortality and Morbidity Studies, Department of Health Sciences, University of Leicester; 2017.
    1. Flenady V, Wojcieszek AM, Middleton P, Ellwood D, Erwich JJ, Coory M, et al. Stillbirths: recall to action in high-income countries. Lancet. 2016;387:691–702. doi: 10.1016/S0140-6736(15)01020-X. - DOI - PubMed
    1. Department of Health. Better Births. https://www.gov.uk/government/news/new-maternity-strategy-to-reduce-the-....
    1. Flenady V, Koopmans L, Middleton P, Frøen JF, Smith GC, Gibbons K, Coory M, Gordon A, Ellwood D, McIntyre HD, Fretts R, Ezzati M. Major risk factors for stillbirth in high income countries: a systematic review and meta-analysis. Lancet. 2011;377(9774):1331–1340. doi: 10.1016/S0140-6736(10)62233-7. - DOI - PubMed
    1. Haws RA, Yakoob MY, Soomro T, Menezes EV, Darmstadt GL, Bhutta ZA. Reducing stillbirths: screening and monitoring during pregnancy and labour. BMC Pregnancy Childbirth. 2009;9(Suppl 1):S5. doi: 10.1186/1471-2393-9-S1-S5. - DOI - PMC - PubMed

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